(Chest. 1999;116:1046-1062.)
© 1999
American College of Chest Physicians
Guidelines in Pulmonary Medicine*
A 25-Year Profile
Dani Hackner, MD;
George Tu, MD;
Scott Weingarten, MD, MPH and
Zab Mohsenifar, MD, FCCP
*
From the Division of Pulmonary Medicine and Critical Care Medicine (Drs. Hackner, Tu, and Mohsenifar), and Health Services Research (Zynx) (Dr. Weingarten), Department of Medicine, Cedars-Sinai Medical Center, University of Los Angeles California, Los Angeles, CA.
Correspondence to: Zab Mohsenifar, MD, FCCP, Room 6732, Cedars-Sinai Medical Center, 8700 Beverly Blvd, Los Angeles, CA 90048
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Abstract
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Objective: We attempted to identify clinical practice
guideline and pathway articles in the area of pulmonary medicine
published in peer-reviewed journals since 1974.
Design: Review.
Data sources: MEDLINE, the
Cochrane Database, Best Evidence, and Abstracts of Clinical Care
Guidelines from January 1974 to December 1998.
Study
selection: All articles contained relevant search terms for
pulmonary topics and were included irrespective of setting (primary or
specialty, inpatient or outpatient). Controlled and uncontrolled trials
as well as observational studies and consensus opinion/statements were
all identified. The articles were stratified by design as well as by
pulmonary topic.
Data extraction: Limited data on
study type, study focus, year of publication, and results of study were
abstracted.
Results: Our criteria yielded 271
articles, including 115 consensus statements and expert opinion
guidelines; 30 controlled studies, meta-analyses, or systematic
reviews; and 126 uncontrolled trials and observational studies.
Of these, 82 articles (30.3%) related to asthma, 46 articles (17.0%)
related to COPD, and 36 articles (13.3%) related to pneumonia. In
addition, we tracked the increasing publication of all
guideline-related pulmonary articles; randomized, controlled trials
(RCTs); systematic reviews; and consensus statements by year for the
past 25 years.
Conclusion: Pulmonary guidelines
are increasingly published in peer-reviewed journals, but few are
tested clinically in RCTs. There is continued reliance on consensus
statements and expert opinion. Pulmonary guideline publications have
continued to dramatically increase in number and in importance since
1974, both on the local level and internationally.
Key Words: asthma COPD emphysema evidence-based medicine pneumonia practice guideline pulmonary review trends
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Introduction
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Clinical
practice guidelines have emerged in large numbers in pulmonary medicine
in the past 25 years. These are statements and protocols for providers
(and in some cases patients) that guide care in specific areas of
medicine. Possible contributing factors include increased managed-care
penetration, emphasis on cost-efficient care, attempts to develop
evidence-based medicine, concern about medico-legal standards, and
quality improvement processes. Do these "clinical practice
guidelines" represent a passing wave in pulmonary medicine? Do
guidelines represent a strong current of evidence-based clinical
practice? To date, no overview of the progress in guideline development
or a description of the types of guidelines exist in the peer-reviewed
pulmonary literature.
With respect to pulmonary disease, clinical practice guidelines
raise certain questions. What kinds of guideline-related articles
appear in the peer-reviewed literature? Can one identify important
consensus-based or expert opinion national guidelines in pulmonary
medicine? To what degree do we rely on published consensus statements
vs rigorous studies? Can one locate key randomized, controlled studies
of guidelines?
Guidelines also raise other questions relevant to medicine generally.
What is the role of nationally developed and consensus-based statements
in relation to local practice and local research? Can locally developed
or studied guidelines be applied at other sites or even nationally?
What is the relative contribution of rigorous randomized, controlled
trials (RCTs) of guidelines and smaller, interventional studies?
Do published guidelines represent the guidelines applied in clinical
practice, or does the literature miss many guidelines?
 |
Goals and Objectives
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We undertook a chronological review of pulmonary medicine
guidelines over the past 25 years, with the primary aim of quantifying
the numbers and types of clinical practice guideline-related
publications in the peer-reviewed pulmonary literature. We also focused
on guidelines in three key pulmonary areas: asthma, COPD, and
pneumonia. Finally, we discuss the trends in publication of pulmonary
practice guidelines.
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Materials and Methods
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Data Sources
In order to identify clinical practice guideline and pathway
articles in pulmonary medicine published in peer-reviewed journals
since 1974, we searched several Ovid databases for articles. MEDLINE
(from 1974 to the second week of December 1998), Best Evidence, and the
Cochrane Library were selected. In addition, we individually reviewed
several core journals (CHEST, American Journal of
Respiratory and Critical Care Medicine, Lancet,
BMJ, New England Journal of Medicine,
Annals of Internal Medicine, and JAMA [Journal of the
American Medical Association]) using the specific search terms
(see below). We also reviewed bibliographies of systematic reviews and
randomized, controlled studies for other articles. Finally, we reviewed
all issues of Abstracts of Clinical Care Guidelines
from 1989 to 1998 for any missed articles. With this strategy, we
attempted to be particularly thorough in three key areas: pneumonia,
asthma, and COPD/emphysema. EMBASE was not included.
Search Terms
Pulmonary articles were selected by these terms: lung*, lung
(MeSH), lung diseases (MeSH), lung diseasesobstructive (MeSH), lung
neoplasms (MeSH), lung transplantation (MeSH), lung volume measurements
(MeSH), pulm*, asthma (MeSH), tuberculosis (TB)pulmonary (MeSH),
pneumo*, pneumonia (MeSH), respir*, respiration (MeSH),
COPD*, COAD*, chronic bronchitis*, emphysema*,
pulmonary emphysema (MeSH), or emphysema (MeSH). Guideline or pathway
topics were selected by these terms: guideline*, practice
guidelines (MeSH), critical pathways (MeSH), critical pathway* or
clinical pathway*. Articles found in both pulmonary AND
guideline/pathway sets were selected. These studies were limited to
human adults
18 years old.
Review Strategy
The aim of this strategy was to broadly categorize any relevant
pulmonary guideline/pathway-related publications, not to
detail the methodological strength of these articles. Two independent
reviewers read and scored abstracts for all of the studies that were
included. For abstracts without stated methodologies, the full-text
articles, published topic reviews, and specific article reviews were
obtained and scored. For controlled studies, all full-text articles
were reviewed and scored. Concealment was not a criterion for review.
Studies of the elements of published guidelines as well as studies of
entire guidelines were included. The reviewers met to resolve
differences in perceived article methodology, topic area, or relevance.
The reviewers encountered one class of articles calling for
future guidelines, and these were excluded. Together with
other articles meeting our inclusion criteria, these are collectively
termed "possibly pulmonary guideline-related articles" in this
review. Other articles excluded were those referring to or studying air
quality guidelines. Articles investigating a specific aspect of an
established guideline were included; however, nonsystematic reviews of
an established guideline were excluded unless a new guideline was
introduced. Also included were guidelines for a specific drug or oxygen
prescription regimen for a pulmonary condition. Finally, articles that
used guideline compliance as a secondary outcome were included.
Article Classification
The articles were identified first by the presence of a control
group and a randomization scheme. Interventional trials
without control subjects were separately identified.
Uncontrolled studies in which no intervention was made were marked as
observational. Consensus statements from societies or government
agencies were earmarked. Statements from a group of authors were
categorized as expert opinion, but were grouped along with consensus
statements. The study focus area was limited to asthma, COPD/emphysema,
pneumonia (nosocomial or community-acquired), or other. The year of
publication since 1974 was used to group the studies into 5-year
categories, ending with the period from 1994 to 1998 (Fig 1
).
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Results
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We obtained 1,582 articles using the search terms
provided above. After limiting the articles to those with
human participants
18 years old, the list contained 593
articles. After a review of the articles, 271 were selected that
contained practice guidelines (with or without pathways) or studies of
guidelines. Tables 1 2
3
summarize the numbers of studies published every 5 years for the past
25 years by publication type (study design) and by pulmonary area. By
pulmonary topic, 82 (30.26%) were asthma articles, 46 (16.97%) were
COPD articles, and 36 (13.28%) were pneumonia articles. The remaining
107 of 269 articles (40.07%) covered diverse pulmonary topics.
One hundred fifteen consensus statements and expert opinion
publications provided guidelines for clinical practice. Tables 4
5
6
7
provide the consensus statements and expert opinion by pulmonary area.
Twenty-four (20.9%) were asthma related, 17 (14.8%) were COPD
related, and 12 (10.4%) were pneumonia related. In other pulmonary
areas, 62 guideline consensus statements were identified (53.9%). From
1994 to 1998, the number of all consensus-based or expert opinion
guidelines varied from 13 (in 1995) to 20 (in 1996). Of interest, only
5 were identified in 1998, a decrease from 17 the previous year. No
decline in studies, randomized or not, was observed for 1998.
Table 8
lists 30 controlled trials (all were randomized except 1
alternating month, controlled trial), as well as systematic reviews.
All of the articles reported studies or systematic reviews of portions
of published practice guidelines or a new guideline. Only five
studies (16.7%) involve a complete practice guideline. Thirteen
of 30 studies (43.3%) were asthma related, 1 (3.3%) was COPD related,
2 (6.7%) were pneumonia related, and 13 (46.7%) related to other
pulmonary topics. Of note, 11 of these rigorous studies (36.7%) were
published in 1998.
One hundred twenty-six studies without a randomization
scheme (or without control subjects) were identified. Designs
ranged from longitudinal studies, to cross-sectional studies, to
prospective interventional studies, to retrospective analyses. By
pulmonary topic, 45 studies (35.7%) were asthma related, 28 (22.2%)
were COPD related, and 22 (17.5%) were pneumonia related. Thirty-one
of 126 studies identified (24.6%) related to other topics. Forty-four
of 126 studies (34.9%) studied areas related to guideline compliance,
either using compliance as a primary or secondary outcome of the study,
or evaluating causes for guideline compliance (or noncompliance).
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Discussion and Analysis
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Consensus Statements
One hundred fifteen consensus statements or expert opinions
recommended specific guidelines for clinical practice (Table 4)
. This
group also included some dose guidelines (eg, theophylline)
or test interpretation guidelines (eg, pulmonary function
study interpretation). Among the first of the consensus-based
guidelines, a guideline for asthma exercise challenge tests by
Eggleston et al14
was published for the American Academy
of Allergy. Subsequently, an oxygen therapy guideline was proposed by
Mak et al47
in 1980. In the years from 1984 to 1988, 11
new consensus statements and expert opinion guidelines in areas such as
emergency treatment of asthma, use of BAL, COPD, out-of-hospital
ventilation, TB and nontuberculous mycoses, and pneumocystis
prophylaxis. In the next 5 years, from 1989 to 1993, 33 consensus
statements and expert opinion guidelines in areas similar to the prior
years were reported in the literature, as well as additional examples
related to community-acquired pneumonia, pneumocystis, and withdrawal
of life-sustaining therapy. Finally, 1994 to 1998 has been a rich
period for national guideline development in TB, sleep apnea, asthma,
smoking prevention and treatment, noninvasive ventilation,
community-acquired pneumonia, COPD and lung volume reduction, acute
lung injury, and lung transplantation. This period accounts for 68
consensus statements and expert opinion-based practice guidelines, 59%
of the total for the past 25 years. Likely, this figure misses many
guidelines that are presented within published studies; however, an
even higher percentage of studies over the past 25 years, 71% of
nonrandomized studies and 80% of randomized trials (or systematic
reviews), occurred in the only the past 5 years (Table 1)
. Most
importantly,
consensus statements and expert opinion continue to hold a prominent
place in the pulmonary guideline literature (Fig 2
).
RCTs
We located 30 prospective, controlled studies,
meta-analyses, and systematic reviews of pulmonary guidelines in the
literature since 1974. Prior to 1982, we did not identify RCTs or
systematic reviews. The first we identified, a study by McConnell et
al,133
studied upper respiratory infections. The earliest
relevant meta-analysis by Tryba141
assessed stress ulcer
prophylaxis and its impact on nosocomial pneumonia outcomes. Several
other stress ulcer prophylaxis studies, including the 1993 study by
Fabian et al,123
have debated the impact on pneumonia with
various gastric pH modifying agents. 1993 was also an important year
for asthma education, heparin nomogram development, and literature
emphasizing rigorous guideline assessment.128
Again, the
most recent 5 years accounted for 80% (24/30) of the systematic
reviews, meta-analyses, and RCTs identified over the past 25 years. In
addition, during 1998 alone 46% (11/24) of the RCTs from the past 5
years have been published. In short, there appears to be a widespread
increase in the published guideline literature, whether opinion-based
or rigorous studies. Still, in comparison with the entire list of
publications of practice guidelines, publications of RCTs still appear
to be few in number (Fig 2)
.
Important Guideline Articles in Asthma, COPD, and
Pneumonia
While there has been a general steep rise in
guideline-related pulmonary publications in the past 2 decades, has the
rise been uniform across pulmonary subject areas? We evaluated the
trends in guideline-related articles in three key pulmonary areas:
asthma, COPD, and pneumonia, both community-acquired and nosocomial
bacterial pneumonia (Fig 2)
. In an effort to be especially
thorough in these areas, we included an expanded list of search terms.
Similar to the trend of increasing consensus statements and studies, in
each of the three selected pulmonary topics, there has been a steady
rise in published guideline-related publications. In addition, we
created a category excluding asthma, COPD, and pneumonia studies, and
still found a consistent rise in the past 2 decades.
Asthma
In the area of asthma, guideline articles have increased
dramatically, with a progression from consensus statements and small
studies to randomized, controlled studies and systematic reviews.
Especially notable are the early papers in asthma that date to 1974;
each 5-year period, publications have more than doubled in number.
Since 1992, national asthma guidelines have been developed in at least
four continents.4
9
10
11
20
23
In turn, there have been
numerous studies documenting guideline noncompliance in asthma as well
as validating metered-dose inhaler guidelines.127
From
1994 to 1998, there have been important randomized trials by Bernstein
et al,118
by van der Molen et al,142
and the
Grampian Asthma Study of Integrated Care group.126
Finally, in 1998, important systematic reviews by the Cochrane
Collaboration evaluated ß-agonist devices, patient education, and
homeopathy in asthma.19
120
125
131
Examples of findings
include that guidelines disseminated with practice-based education may
improve asthma management in inner cities and possibly allow cost
savings in chronic disease management. They also found that structured
consultation recommended by the guidelines improved
compliance.125
In addition to increasing rigorous, controlled studies in the asthma
literature, dissemination and study of guidelines appears to be leading
to change in practice. In asthma, national consensus statements may
play a crucial role. Spelman146
studied how the
implementation of British Thoracic Society (BTS) asthma
guidelines resulted in a substantial change in local bronchodilator
use. These national consensus statements may serve as public domain
guidelines and may establish standards of care for a region. In
addition, they may spur the development of locally tailored practice
guidelines. After the adoption of locally developed guidelines in East
London, quality of prescribing improved.124
Similar
results have been observed in Saskatchewan after local implementation
of national guidelines.147
In short, guideline
dissemination may be affecting local practice patterns as well as
stimulating local guideline development.
In the area of asthma, local studies of practice guideline may validate
or place in question an element of national guidelines. Bernstein et
al148
tested the safety and outcomes of inhaled
corticosteroid treatment in mild-to-moderate asthma, consistent with
the recommendations of the National Institutes of Health (NIH)
guideline. On the other hand, Haahtela et al149
have
reported clinical benefits with a treatment not in the current NIH
asthma guideline: inhaled corticosteroid treatment for mild asthma.
Their study suggested a program of long-term therapy of mild asthma
aimed at reducing inflammation with inhaled steroids. Maintenance doses
were lower than quantities reported to initially normalize lung
function and appeared to show long-term disease stabilization. The
authors recommend validation of their findings in a clinical practice
setting. These asthma studies suggest a pattern for guideline-based
quality improvement, beginning with an expert opinion practice
guideline, leading to studies that challenge or validate elements of
the guideline, and finally resulting in trials of new practice
guidelines.
Pneumonia
In pneumonia, the guideline literature has developed recently.
Eighty-nine percent of pneumonia-related publications have occurred in
the past 5 years (Table 3)
. Two paths have emerged recently in
the literature, one starting with consensus statements and the other
beginning with early evidence-based approaches. Along the first path,
the American Thoracic Society (ATS) published a community-acquired
pneumonia guideline in 1993.29
The guideline was based on
an empiric strategy, in large part to the paucity of prior research and
clinical information available. Subsequently, the ATS approach has been
validated in part by Gordon et al150
in 1996. Similarly,
the BTS guidelines have been studied by Neill et al.151
In
addition, several other studies have evaluated various aspects of these
national pneumonia guidelines from infectious etiologies to local
compliance.28
29
30
Internationally, the 1993 ATS guideline,
along with the Canadian-published guideline by Mandell and
Niederman,35
has paved the way for several other
countries, including the Italian guidelines in 1995, South African in
1996, and Dutch in 1997 and 1998.25
33
34
35
36
A second path in the area of pneumonia was paved by evidence-based
studies. Notable pneumonia guideline studies by Weingarten et
al144
in 1994, Leroy et al152
in 1996, and
Fine et al153
in 1997 have originated low-risk criteria or
prognostic scores for pneumonia. These focused prognostic and
diagnostic tools may be amenable to large studies, and they may be
portable from center to center. As national guidelines are revised, the
incorporation of key elements such as a risk stratification tool may be
effective. Another evidence-based highlight is the systematic review by
Cook et al121
on nosocomial pneumonia ventilator
management in 1998. In summary, in the area of pneumonia, there have
been two productive paths: one with evidence-based, outcomes-oriented
local studies and a second with consensus-based national guidelines.
Both have led to validated approaches to pneumonia care.
COPD
Also recently, COPD studies have emerged in the literature (Table 5) . Seventy percent of COPD studies we identified occurred in only the
past 5 years. In 1996, several important COPD guideline-related reports
were published (Table 6)
. Following on the heels of earlier COPD
guidelines by the Canadian Thoracic Society39
and the
European Respiratory Society study on COPD,48
Siafakas et
al50
in Europe and Celli38
in the
United States published their national guidelines. In addition, in
1996, guidelines for lung volume reduction surgery (LVRS) were
published by Criner et al,42
by Holohan,46
and
by Yusen and Lefrak.53
Subsequently, due to the paucity of
rigorous, controlled outcomes studies in the area of LVRS for COPD, the
guidelines for lung volume reduction have been formulated into the
National Emphysema Treatment Trial (NETT). The NETT randomizes Medicare
patients to LVRS following rehabilitation or to rehabilitation alone.
In addition to physiologic outcomes such as pulmonary function and
exercise testing, health-related quality of life are being be
assessed.154
The NETT study marks an important
intersection between national guidelines and outcomes studies. Large
studies of its kind may represent a move toward national managed care
of costly but unproven therapies. In contrast to private payor-driven
guidelines, its results will be public and subject to peer review.
Questions Raised About Guidelines and Outcomes Studies
Large outcomes studies such as the NETT raise important questions.
First, what is the difference between clinical practice guidelines with
careful monitoring of outcomes and carefully designed outcomes studies?
One important distinction is between study designs that integrate
explicit practice guidelines and designs that address guideline-related
issues, such as metered-dose inhaler recommendations from asthma
guidelines. Our review does not attempt to separate the two; in the
area of RCTs, there are even fewer explicit trials of complete
guidelines compared to the large number of studies that evaluate
portions of consensus guidelines. Large trials such as the NETT study
also include repeated measures that would not likely be part of a
practice guideline due to expense. An economic analysis of the
cost-effectiveness of large RCTs vs observational studies may help
design affordable implementation and validation strategies. An analysis
may also be needed to assess the most cost-effective means to monitor
long-term outcomes and ongoing compliance.
Large guideline trials and outcomes studies like the NETT have raised
ethical questions as well. The NETT requires participation in the study
for Medicare funding of lung volume reduction. In a sense, it functions
as an approved national guideline. What is the impact of linking
insurance payments to (experimental) guideline compliance with respect
to patient autonomy, confidentiality, and distributive justice? After
extensive review by ethics panels, the NETT was approved. Still, in the
future these concerns will continue to surface as guideline outcomes
data are aggregated on national guidelines.
Aside from large trials, how common do guidelines evolve from a
systematic, evidence-based approach? Naylor et al155
reviewed strategies for guideline development and research promotion.
Using the example of pulmonary artery (PA) catheterization, they found
only six randomized, controlled studies of PA catheterization
guidelines or protocols. None of the published guidelines used a formal
group process together with a hierarchical review of evidence to
develop PA catheter indications. To date, no in-depth data exist on the
fraction of guidelines that are evidence-based in the pulmonary
literature.
Questions Raised About Unpublished Guidelines
Peer-reviewed studies and statements may only be the tip of a
large unpublished guidelines and pathways iceberg. In our center, there
are at least 59 guidelines and pathways in medicine, surgery,
pediatrics, obstetrics/gynecology, and psychiatry. Of the 17 medicine
guidelines, only 5 have been published and only 2 of these are
pulmonary related.
In a competitive market environment, health systems may have financial
incentives to develop guidelines. Especially in markets with high
managed-care penetration, guidelines may be an economic imperative for
the survival of a health-care system. One guideline illustrates
how limited outcomes may have a significant financial impact on the
medical center. Bailey et al156
studied the acute
exacerbation of asthma in adults, validating it in a retrospective
study of 42 patients. Nineteen patients were enrolled in the pathway
over a 6-month period in 1995. Thirty-eight similar patients from 1994
were historical controls. A significant increase in conversion from
hand-held nebulizer to metered-dose inhaler was observed: 68% vs 34%
(p < 0.05) comparing to the nonpathway group, and 68% vs 26%
(p = 0.002) comparing to the 1994 historical control group, resulting
in a significant cost savings of $288,000 per year.
Despite the economic imperative to develop competitive guidelines, some
health systems may have no incentive to publish the guidelines.
In addition to potentially giving a financial boost to a rival system,
a guideline could incur liability for those who develop guidelines.
Hyams et al157
raised questions about how guidelines have
been used in the "two-way street" of the courts, in which
plaintiffs may have more frequently used guidelines, although the
interpretation of their data has been disputed.158
On the
other hand, Noble et al159
have also highlighted a case of
medical negligence due to the failure to adopt guidelines in a blood
bank.
Other factors possibly impeding guideline dissemination include
publication bias and the cost of performing clinical studies. Negative
outcomes studies may be seen as adverse publicity for a quality
improvement "failure." Academic factors in particular may favor
studies of practice guidelines. The indirect benefits of publication
may not be incentive enough for nonacademic centers to publish. Even at
academic centers, the sharing of medical developments may be minimized
by increasing clinical workloads; physicians may not be able to justify
spending time on unreimbursed activities such as conference
participation and guideline publication.
Toward Improving the Guideline Process: Funding, Oversight, and
Appropriate Applications
One potential solution, the additional funding of guideline
research and development, may reward those who publish. Unfortunately,
simply funding more guideline development may not reward successful
guidelines or competitive guidelines. Moreover, participants in
guideline development may have competing motivations. Some systems may
simply wish to minimize costs without necessarily improving quality.
Others, such as medical societies or provider groups (such as advanced
practice nurses and pharmacists) may be eager to promote a certain
provider's involvement or increase referrals. Advocates may promote a
particular model of care, such as "disease management," "primary
care," or the "hospitalist" model. Health systems that are
heavily invested in certain services, procedures, devices, or drugs may
develop guidelines to enhance their utilization. Poor guideline
development could be costly and counterproductive in global health-care
budgets.
The oversight of guidelines by government or private agencies could
improve accountability in the design of guidelines. It could also lead
to the wider publication of guideline experience. Examples of agencies
that promoted guideline development include the Joint Commission on
Accreditation of Healthcare Organizations, the National Committee for
Quality Assurance, and the American Medical Accreditation Program, with
their collaborative Performance Measurement Coordinating
Council.160
Other examples include the efforts of the
Agency for Health Care Policy and Research (AHCPR) to fund and
influence performance through evidence-based medicine. Notable AHCPR
products include the guidelines on smoking cessation and the
cost-effectiveness study of cessation guidelines that revealed
favorable findings of low cost per quality-adjusted life year
saved.55
161
Possible hazards of a centralized or
government approach include overregulation, slowed guideline
development, and further increased costs. For instance, in the area of
infection control, efforts led by the Joint Commission on Accreditation
of Healthcare Organizations have been linked to new hospital
expenditures on new practice guidelines, but we still lack data that
quality of health care has been improved.162
Some
important areas for future research include economic analyses of the
impact of guidelines on large health systems, their patients, and their
providers.
Can a locally-developed guideline be applied to another site or even
adopted nationally? Guidelines originating in one locale may have
markedly different outcomes at other centers due to regional or
institutional factors.163
In some areas, nationally
disseminated guidelines may not necessarily improve care, as
Weingarten164
has pointed out. But without publication of
local experience, guideline failures (and successes) may go unnoticed;
health systems involved in new guideline development may be forced to
repeat others' mistakes or to reinvent the wheel. Cross-sectional
studies of geographic variability in guideline content and compliance
may be needed to identify regions with implementation success and those
needing new approaches.
To answer how published guidelines relate to current practice, a large,
questionnaire-based study would be needed. A similar study would be
needed to address the relationship between unpublished and published
guidelines. Furthermore, longitudinal studies may be needed to link
practice guidelines with the improvement of ongoing clinical processes
and outcomes.17
Such studies may address the important
relationship between "community standard" of care and
"evidence-based" care, as well as the issue of compliance.
Limitations of This Review
This review attempted to identify pulmonary-related practice
guidelines and studies of those guidelines in the peer-reviewed
literature using an explicitly stated review strategy. By including
prior versions of guidelines, we avoided a natural bias to more
recently published reports. By using keyword as well as MeSH terms
(some of which did not exist years ago), we also hoped to avoid bias
toward recent reports. Although we minimized some of that bias, we
still are limited by the term "guideline" itself, and synonyms may
have appeared in the earlier literature (recommendations, protocols,
procedures, outlines, flow-charts, and others). This bias may have been
minimized by using other references such as Abstracts of Clinical
Care Guidelines, from early 1989 (which identifies earlier
guidelines), but these other references carry their own biases.
Some of the publications are strictly-speaking, not peer-reviewed, but
are official publications of national organizations, such as the NIH.
These too were referenced by some of the included articles and
guideline abstracts, and we believed they were important to include. We
also included articles that incorporated clinical pathways as well as
guidelines, but we did not review pathways alone in any detail. As
discussed, the list of randomized, controlled studies of
guideline-related issues includes few studies of entire guidelines.
This illustrates the paucity of rigorous, controlled guideline studies.
Most of all, this study does not detail specific subject areas that
deserve separate systematic review, meta-analysis, or overview.
 |
Conclusion
|
|---|
Pulmonary guidelines are increasingly published in peer-reviewed
journals over the past 25 years. We can identify important
consensus-based or expert opinion national guidelines in pulmonary
medicine. We can also locate rigorous, controlled studies and
meta-analyses of practice guidelines. Likewise, we have found many
studies of key portions of published national guidelines and consensus
statements. These rigorous studies and reviews are increasing, as well
as small, nonrandomized studies. However, 1998 has seen a decrease in
consensus-based and expert opinion guidelines. Despite the decrease in
published consensus-based guidelines in 1998, all trials of pulmonary
guidelines continued to increase in the past year. In all, clinical
practice guidelines do not appear to be a passing wave in pulmonary
medicine.
Do guidelines represent a strong current of evidence-based clinical
practice? In general, few guidelines have been tested clinically in
RCTs or are subject to systematic review. In areas such as COPD,
pneumonia, and asthma, where national guidelines have been
disseminated, multiple uncontrolled clinical studies relating to the
guidelines have been published and in some cases serve to modify
national guidelines. In addition, controlled studies of portions of
these guidelines are appearing in the literature. In addition, though
national consensus statements are no replacement for large RCTs (and
can potentially interfere with RCTs), they may lead to large and
potentially useful administrative data collections.
National guidelines may lead to both local and international guideline
development. As costly choices may be faced on the national level,
national guidelines may be mandatory for certain federally funded
procedures or treatments. In certain areas such as pneumonia, rather
than attempting a full-scale adoption of locally developed guidelines,
key portions of guidelines, validated in outcomes studies, may make
their way into national guidelines. But where local guidelines only
serve as proprietary, internal health system protocols, their merits or
failures will likely be missed in the published, peer-reviewed
literature.
Finally, there are several factors that may impede guideline
dissemination and study, from publication bias and legal issues to cost
and competition. Yet despite any disincentive to publish, pulmonary
guideline publications have continued to dramatically increase in
number and in importance on the local and the international level.
A more comprehensive study of pulmonary guidelines is needed. It should
survey health systems and experts in pulmonary medicine or guideline
development. Such a study would assist in tracking guidelines and
locating important studies. The ability to track the numbers and types
of practice guidelines may eliminate redundant efforts and may locate
areas needing additional practice guideline development. In addition, a
comprehensive guideline study may identify unpublished practice
guidelines and published guidelines that are changing community
standards of care.
 |
Footnotes
|
|---|
Abbreviations: AHCPR = Agency for Health Care
Policy and Research; ATS = American Thoracic Society; BTS = British
Thoracic Society; LVRS = lung volume reduction surgery;
NETT = National Emphysema Treatment Trial; NIH = National
Institutes of Health; PA = pulmonary artery; RCT = randomized,
controlled trial
Received for publication March 1, 1999.
Accepted for publication May 12, 1999.
 |
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